efficacy and safety of jt001 (vv116) compared with paxlovid

Conditions: COVID-19

Summary: the purpose of this study is to evaluate the efficacy and safety of jt001 (vv116) compared with paxlovid for the treatment of coronavirus disease 2019 (covid-19) in participants with mild to moderate covid-19.

screening interested participants will sign the appropriate informed consent form (icf) prior to completion of any study procedures. the investigator will review symptoms, risk factors and other non-invasive inclusion and exclusion criteria prior to any invasive procedures. treatment and assessment period this is the general sequence of events during the 28-day treatment and assessment period: complete baseline procedures participants are randomized to an intervention group participants receive study intervention (q12h x 5 days), and complete all safety monitoring

Eligibility criteria:
inclusion criteria: * participants who have a positive sars-cov-2 test result. * participants who have one or more mild or moderate covid-19 symptoms, and total symptom score ≥ 2. * participants who have one or more of the following requirements: ≤7 days from the first positive test for sars-cov-2 virus infection to the first dose; ≤5 days from the first onset of covid-19 symptoms to the first dose; sars-cov-2 ct value ≤20 within 24 hours prior to the first dose. * participants who satisfy one or more than one of the following high risks for progression to severe covid-19, including death. * participants who must agree to adhere to contraception restrictions. * participants who understand and agree to comply with planned study procedures. * participants or legally authorized representatives can give written informed consent approved by the ethical review board governing the site. * capable of giving signed informed consent as described in appendix 1 which includes compliance with the requirements and restrictions listed in the informed consent form (icf) and in this protocol. exclusion criteria: * participants who are judged by the investigator as likely to progress to severe/critical covid-19 prior to randomization. * participants who have spo2≤93% on room air at sea level or pao2/fio2≤ 300, or respiratory rate ≥30 per minute. * participants who require mechanical ventilation or anticipated impending need for mechanical ventilation. * participants who have eye disease. * participants who have any of the following conditions when screening: alt or ast\>1.5 uln; e gfr \<60 ml/min. * participants who have known allergies to any of the components used in the formulation of the interventions. * any medical condition, which in the opinion of the investigator, will compromise the safety of the participant. * participants who have received a sars-cov-2 monoclonal antibody treatment or prevention, or antiviral treatment (including the investigational treatment). * participants who have received convalescent covid-19 plasma treatment. * participant's use of contraindicated drugs in the package insert of nirmatrelvir tablet/ritonavir tablets. * participants who have participated, within the last 30 days, in a clinical study involving an investigational intervention. if the previous investigational intervention has a long half-life, 5 half-lives or 30 days, whichever is longer, should have passed. * participants who are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study. * female who is pregnant or breast-feeding or plan to be pregnant within this study period. * male whose wife or partner plan to be pregnant within this study period.

Keywords: jt001(vv116) mild to moderate covid-19